A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced BreastCancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal

Assessments of health-related quality of life will be performed using the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life core questionnaire (QLQ-C30) and breast cancer module(QLQ-BR23) at specified intervals and at time of disease progression.

To determine the percent of androgen receptor (AR) nuclear expression and signaling in breast tissue and to evaluate the relationship of this expression with enzalutamide effects on circulating tumor biomarkers, circulating hormones, and clinical outcomes.

Enzalutamide 160 mg/day administered as four 40-mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg tablet once daily after food.

Drug: Enzalutamide

160 mg/day administered as four 40-mg soft gelatin capsules by mouth once daily with or without food.

Other Names:

MDV3100

XTANDI

Drug: exemestane

25 mg or 50 mg tablet administered as a single capsule by mouth once daily after food.

Active Comparator: placebo & exemestane

placebo and exemestane 25 mg once daily after food.

Drug: exemestane

25 mg or 50 mg tablet administered as a single capsule by mouth once daily after food.

Drug: Placebo (for enzalutamide)

Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.

Detailed Description:

This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal.

Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed;

Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report;

Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible;

ECOG status of 0 or 1;

Exclusion Criteria:

Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator;

Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator;

Current or previously treated brain metastasis or leptomeningeal disease;

Prior therapy (> 28 days) with exemestane in the metastatic setting (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible);

Requires treatment for tuberculosis or HIV infection;

Radiation therapy within 7 days before randomization;

History of another invasive cancer within 5 years before randomization;

History of seizure or any condition that may predispose to seizure;

Clinically significant cardiovascular disease;

Active gastrointestinal disorder;

Major surgery within 28 days prior to randomization;

Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization;

Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor;

Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides;

Hypersensitivity reaction to exemestane.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT02007512